Shape memory segmented detachable coil

ABSTRACT

The shape memory segmented detachable coil assembly includes a plurality of hollow, tubular coil segments, and a plurality of connector members, with adjacent coil segments connected together by the connector members. The connector members are currently preferably hollow, tubular connector members that are advantageously detachable from selected portions of the coil segments by application of energy to one or more selected connector members. A heat activation member is used for heating one or more selected connector members to disconnect selected portions of the coil assembly. The heat activation member typically can be advanced axially through or over the coil assembly, and currently preferably comprises a fiber optic, although the heat activation member can also comprise a heat pipe, or a device for generating heat by RF energy or electrical resistance.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to implantable devices forinterventional therapeutic treatment or vascular surgery, and moreparticularly concerns an occlusion coil assembly with defined segmentsattached together by connector members that can be activated to releasedesired selected segments of the coil assembly.

2. Description of Related Art

Interventional vascular therapy and surgery has recently involved theuse of catheters to place therapeutic devices at a treatment site byaccess through the vasculature. Examples of such procedures includetransluminal angioplasty, placement of stents to reinforce the walls ofa blood vessel or the like and the use of vasoocclusive devices to treatdefects in the vasculature. One specific field of interventional therapythat has been able to advantageously use recent developments intechnology is the treatment of neurovascular defects. One type ofnon-surgical therapy that has become advantageous for the treatment ofdefects in the neurovasculature has been the placement of vasoocclusivedevices by way of a catheter in a damaged portion of a vein or artery.

Vasoocclusion devices are therapeutic devices that are placed within thevasculature of the human body, typically via a catheter, either to blockthe flow of blood through a vessel making up that portion of thevasculature through the formation of an embolus or to form such anembolus within an aneurysm stemming from the vessel. The vasoocclusivedevices can take a variety of configurations, and are generally formedof one or more elements that are larger in the deployed configurationthan when they are within the delivery catheter prior to placement. Onewidely used vasoocclusive device is a helical wire coil having adeployed configuration which may be dimensioned to engage the walls ofthe vessels. One anatomically shaped vasoocclusive device that formsitself into a shape of an anatomical cavity such as an aneurysm and ismade of a pre-formed strand of flexible material that can be anickel-titanium alloy is known from U.S. Pat. No. 5,645,558, which isspecifically incorporated by reference herein. That vasoocclusive devicecomprises one or more vasoocclusive members wound to form a generallyspherical or ovoid shape in a relaxed state. The device is sized andshaped to fit within a vascular cavity or vesicle, such as for treatmentof an aneurysm or fistula. The vasoocclusive member can be firsthelically wound or braided in a generally linear fashion, and is thenwound around an appropriately shaped mandrel or form, and heat treatedto retain the shape after removal from the heating form. Radiopacity canbe provided in the vasoocclusive members by weaving in synthetic ornatural fibers filled with powdered radiopaque material, such aspowdered tantalum, powdered tungsten, powdered bismuth oxide or powderedbarium sulfate, which can potentially be released during vascularsurgery.

The delivery of such vasoocclusive devices can be accomplished by avariety of means, including via a catheter in which the device is pushedthrough the catheter by a pusher to deploy the device. The vasoocclusivedevices, which can have a primary shape of a coil of wire that is thenformed into a more complex secondary shape, can be produced in such away that they will pass through the lumen of a catheter in a linearshape and take on a complex shape as originally formed after beingdeployed into the area of interest, such as an aneurysm. A variety ofdetachment mechanisms to release the device from a pusher have beendeveloped and are known in the art.

For treatment of areas of the small diameter vasculature such as a smallartery or vein in the brain, for example, and for treatment of aneurysmsand the like, micro-coils formed of very small diameter wire are used inorder to restrict, reinforce, or to occlude such small diameter areas ofthe vasculature. A variety of materials have been suggested for use insuch micro-coils, including nickel-titanium alloys, copper, stainlesssteel, platinum, tungsten, various plastics or the like, each of whichoffers certain benefits in various applications. Nickel-titanium alloysare particularly advantageous for the fabrication of such micro coils,in that they can have super-elastic or shape memory properties, and thuscan be manufactured to easily fit into a linear portion of a catheter,but attain their originally formed, more complex shape when deployed.

In some applications, it has been found that the correct length of suchmicrocoil occlusive devices for use at a treatment site in thevasculature is only determined after delivery of the device. Thus,typically a physician will choose a standard length, such as a 20 cmcoil, for example, without knowing that only a 15 or 16 cm coil is theproper length. When it is discovered that a shorter coil is required,the entire coil needs to be removed and replaced with a shorter coiltaking time to withdraw and replace with the proper length. In addition,if it is discovered that a longer coil is required, another proceduremust be performed to supply the additional coil length. In either case,the entire treatment procedure is prolonged, resulting in potentialtrauma to the patient.

A need therefore remains for a microcoil occlusive device that willallow the precise required length of coil to be supplied to a desiredtreatment site in a minimally traumatic procedure. It would be desirableto provide a device that allows a physician to introduce a coil of amplelength for any given treatment site in the vasculature, detach one ormore desired coil lengths at the treatment site, and reposition thecatheter and continue to deploy the remaining coil segments as desired,in a single procedure. The present invention meets these and otherneeds.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention provides for anocclusion coil assembly composed of detachable segments that can bedetached and placed as desired at one or more vascular treatment sites,for use in interventional therapy and vascular surgery.

The invention accordingly provides for an occlusion coil assembly foruse in interventional therapy and vascular surgery, adapted to beinserted into a portion of a vasculature of a patient. The occlusioncoil assembly includes a plurality of hollow, tubular coil segments, anda plurality of connector members, with adjacent coil segments connectedtogether by the connector members. The connector members are currentlypreferably hollow, tubular connector members that are advantageouslydetachable from selected portions of the coil segments by application ofenergy to one or more selected connector members. In a currentlypreferred embodiment, the connector members are formed of a shape memorymaterial, preferably having a glass transition temperature (T_(g)) abovebody temperature, and having a desired stressed configuration at atemperature appropriate for introduction into the body via a catheter,and a more relaxed, unstressed original shape that is assumed uponactivation for releasing the endoluminal therapeutic device. The shapememory material is currently preferably a shape memory polymer, such aspolyurethane, heat shrink tubing such as polyethylene terephthalate(PET) or high density polyethylene (HDPE), although the shape memorymaterial may alternatively be a shape memory metal such as nickeltitanium alloy, such as that available under the trade name NITINOL, forexample, that can be heat treated to have shape memory behavior.

The shape memory material sections are currently preferably secured tothe coil segments by crimping a distal portion of a shape memorymaterial connector member over a proximal portion of a segment of thecoil assembly, and securing, such as by gluing, a proximal portion ofthe shape memory material connector member over a distal portion of asegment of the coil assembly. Alternatively, the shape memory materialconnector members can be secured to the coil segments such as by gluinga distal portion of a shape memory material connector member over aproximal portion of a coil segment, and crimping a proximal portion ofthe shape memory material connector member over a distal portion of acoil segment. As the sections are detached by heat activation, theactivated shape memory material connector member radially opens andaxially shrinks, separating one or more distal coil segments from theproximal portion of the coil assembly.

In operation of the occlusion coil assembly, a heat activation member isalso preferably provided for heating one or more selected connectormembers to disconnect selected portions of the coil assembly. The heatactivation member typically can be advanced and retracted axiallythrough the middle of the coil assembly, or by means of a catheter thathas a light source at the distal tip, for example, and currentlypreferably comprises a fiber optic, although the heat activation membercan also comprise a heat pipe, or a device for generating heat by RFenergy, or by electrical resistance, and the like.

From the above, it can be seen that the present invention provides animproved coil assembly that is more easily adapted to placement of coilswithout the risk of using an inappropriate length and the subsequentwithdrawal and replacement of the coil by the therapist. These and otheraspects and advantages of the invention will become apparent from thefollowing detailed description and the accompanying drawings, whichillustrate by way of example the features of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of the occlusion coil assembly of thepresent invention;

FIG. 2 is a cross-sectional view of the occlusion coil assembly of FIG.1;

FIG. 3 is a cross-sectional view similar to FIG. 2, illustratingactivation of a connector member and release of a segment of theocclusion coil assembly; and

FIG. 4 is a cross-sectional view of an alternative embodiment of a heatactivation member for release of a segment of the occlusion coilassembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the delivery of microcoil occlusive devices to a vascular treatmentsite, it is frequently necessary to remove and replace an incorrectlength of the microcoil occlusive device with one of a desired length,requiring additional procedures and often causing further prolonged to apatient being treated.

As is illustrated in the drawings, the invention is accordingly embodiedin an occlusion coil assembly 10 composed of a plurality of hollow,generally tubular coil segments 12 connected together by shape memorymaterial connector members 14. The connector members are preferablyformed of a shape memory material having a glass transition temperature(T_(g)) above body temperature, and having a desired stressedconfiguration at a temperature appropriate for introduction into thebody via a catheter, and a more relaxed, unstressed original shape thatis assumed upon activation for releasing the endoluminal therapeuticdevice. The shape memory material is currently preferably a shape memorypolymer, such as polyurethane, heat shrink tubing such as polyethyleneterephthalate (PET) or high density polyethylene (HDPE), although theshape memory material may alternatively be a shape memory metal such asnickel titanium alloy, such as that available under the trade nameNITINOL, for example, that can be heat treated to have shape memorybehavior.

The shape memory material connector members preferably have a stressedhollow, tubular configuration, and retract axially and expand radiallywhen heated. Thus, in one currently preferred embodiment, the connectormembers can be secured in a stressed configuration to the coil segmentsby crimping a distal portion 16 of a shape memory material connectormember over a proximal portion 18 of a distally adjacent segment of thecoil assembly, and securing a proximal portion 20 of the shape memorymaterial connector member over a distal portion 22 of a proximallyadjacent segment of the coil assembly, such as by gluing withcyanoacrylate adhesive, for example. Alternatively, the shape memorymaterial connector members can be secured in a stressed configuration tothe coil segments, such as by gluing a distal portion of a shape memorymaterial connector member over a proximal portion of a distally adjacentcoil segment, with cyanoacrylate adhesive for example, and crimping aproximal portion of the shape memory material connector member over adistal portion of a proximally adjacent coil segment. When aligned andconnected end to end, the coil assembly can typically form a coil about30 cm long, while individual segments can typically be about 2 cm long.

The shape memory material connector members preferably can be caused todisconnect selected portions of the coil assembly by activation with aheat activation member 24, such as a fiber optic, that can be threadedthrough the coil segments although other heat transmission members suchas a heat pipe, or a device generating heat by RF energy, or byelectrical resistance, for example, may also be suitable. As thesections are detached by heat activation, the activated shape memorymaterial connector member radially opens and axially shrinks, separatingone or more distal coil segments from the proximal portion of the coilassembly.

In an alternative embodiment illustrated in FIG. 4, a heat activationmember can also be threaded over the outside of the occlusion coilsegments and connector members, such as a fiber optic tube 26 with anetched heat dissipation ring portion 28 that can be advanced andretracted within a catheter 30 along a coil assembly, and positionedaround a desired connector member for heating and activating theconnector member to release one or more coil segments, as describedabove. The heat activation member may advantageously be provided with aradiopaque section 32, such as a platinum, gold, or tungsten coil, forexample, to allow the heat activation member to be imaged; and the coilsegments may also be provided with similar radiopaque material to allowthe coil segments to be imaged during placement at a vascular treatmentsite.

It will be apparent from the foregoing that while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

What is claimed is:
 1. An occlusion coil assembly for use ininterventional therapy and vascular surgery, comprising: a plurality ofhollow, tubular coil segments; and at least one hollow, tubularconnector member, adjacent ones of said coil segments being connectedtogether by said connector member, said connector member beingdetachable from selected portions of said coil segments by applicationof energy to said connector member.
 2. The occlusion coil assembly ofclaim 1, further comprising a plurality of connector members.
 3. Theocclusion coil assembly of claim 1, wherein said connector member isformed from a shape memory material.
 4. The occlusion coil assembly ofclaim 3, wherein said shape memory material has a desired stressedconfiguration at a temperature appropriate for introduction into thebody via a catheter, and after placement, will take on a more relaxed,unstressed original shape for releasing the endoluminal therapeuticdevice.
 5. The occlusion coil assembly of claim 3, wherein said shapememory material comprises a shape memory polymer selected from the groupconsisting of polyurethane, heat shrink tubing, polyethyleneterephthalate, and high density polyethylene.
 6. The occlusion coilassembly of claim 3, wherein said shape memory material is a nickeltitanium alloy.
 7. The occlusion coil assembly of claim 1, wherein saidconnector member is secured to adjacent coil segments by crimping adistal portion of one of said connector members over a correspondingproximal portion of a distally adjacent coil segment, and gluing aproximal portion of said connector member over a distal portion of acorresponding proximally adjacent coil segment.
 8. The occlusion coilassembly of claim 1, wherein said connector member is secured toadjacent coil segments by crimping a proximal portion of one of saidconnector member over a corresponding distal portion of a proximallyadjacent coil segment, and gluing a distal portion of said connectormember over a proximal portion of a corresponding distally adjacent coilsegment.
 9. The occlusion coil assembly of claim 1, further comprising aheat activation member that can be advanced and retracted axiallythrough said coil segments and said connector members for heatingselected ones of said connector members to disconnect selected coilsegments.
 10. The occlusion coil assembly of claim 9, wherein said heatactivation member comprises a fiber optic.
 11. The occlusion coilassembly of claim 9, wherein said heat activation member comprises aheat pipe.
 12. The occlusion coil assembly of claim 9, wherein said heatactivation member comprises a device for generating heat by RF energy.13. The occlusion coil assembly of claim 9, wherein said heat activationmember comprises a device for generating heat by electrical resistanceheating.
 14. The occlusion coil assembly of claim 1, further comprisinga heat activation member that can be advanced and retracted axially oversaid coil segments and said connector members for heating selected onesof said connector members to disconnect selected coil segments.
 15. Theocclusion coil assembly of claim 14, wherein said heat activation membercomprises a fiber optic.
 16. The occlusion coil assembly of claim 14,wherein said heat activation member comprises a device for generatingheat by RF energy.
 17. The occlusion coil assembly of claim 14, whereinsaid heat activation member comprises a device for generating heat byelectrical resistance heating.
 18. An occlusion coil assembly for use ininterventional therapy and vascular surgery, comprising: a plurality ofhollow, tubular coil segments; a plurality of connector members,adjacent ones of said coil segments being connected together by one ofsaid connector members, said connector members being detachable fromselected portions of said coil segments by application of energy toselected ones of said connector members; and a heat activation memberthat can be advanced and retracted axially adjacent to said coilsegments and said connector members for heating selected ones of saidconnector members to disconnect selected coil segments.
 19. Theocclusion coil assembly of claim 18, wherein said connector members areformed from a shape memory material.
 20. The occlusion coil assembly ofclaim 19, wherein said connector members have a hollow, tubularconfiguration.
 21. The occlusion coil assembly of claim 19, wherein saidshape memory material has a desired stressed configuration at atemperature appropriate for introduction into the body via a catheter,and after placement, will take on a more relaxed, unstressed originalshape for releasing the endoluminal therapeutic device.
 22. Theocclusion coil assembly of claim 19, wherein said shape memory materialcomprises a shape memory polymer selected from the group consisting ofpolyurethane, heat shrink tubing, polyethylene terephthalate, and highdensity polyethylene.
 23. The occlusion coil assembly of claim 19,wherein said shape memory material is a nickel titanium alloy.
 24. Theocclusion coil assembly of claim 18, wherein said connector members aresecured to adjacent coil segments by crimping a distal portion of one ofsaid connector members over a corresponding proximal portion of adistally adjacent coil segment, and gluing a proximal portion of saidconnector member over a distal portion of a corresponding proximallyadjacent coil segment.
 25. The occlusion coil assembly of claim 18,wherein said connector members are secured to adjacent coil segments bycrimping a proximal portion of one of said connector members over acorresponding distal portion of a proximally adjacent coil segment, andgluing a distal portion of said connector member over a proximal portionof a corresponding distally adjacent coil segment.
 26. The occlusioncoil assembly of claim 18, wherein said heat activation member comprisesa fiber optic.
 27. The occlusion coil assembly of claim 18, wherein saidheat activation member comprises a heat pipe.
 28. The occlusion coilassembly of claim 18, wherein said heat activation member comprises adevice for generating heat by RF energy.
 29. The occlusion coil assemblyof claim 18, wherein said heat activation member comprises a fiber optictube having an etched heat dissipation ring portion.
 30. The occlusioncoil assembly of claim 18, wherein said heat activation member comprisesa device for generating heat by electrical resistance heating.